EFFECT OF LIGHT REDUCTION ON RETINOPATHY OF PREMATURITY

减光对早产儿视网膜病变的影响

• 批准号: 3443828
• 负责人: RAND SPENCER
• 金额: $ 7.65万
• 依托单位: BAYLOR RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-08-15 至 1992-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3443828
• 关键词: clinical trials; epidemiology; health science research analysis /evaluation; human subject; injury prevention; light adverse effect; light intensity; longitudinal human study; nursery; premature infant human; retinopathy of prematurity

This is one of three interrelated applications for financial support to plan multi-protocol clinical-epidemiologic research involving retinopathy of prematurity (ROP). The objective of this proposed clinical trial is to study the effects of light reduction on retinopathy of prematurity. This application is for support of the detailed planning phase necessary to: . Develop a detailed manual of procedures . Recruit clinical centers . Document recruitment potential . Perform a pilot phase of the study in order to refine procedures and forms . Prepare a grant application for the clinical trial phase. ROP is a cause of blindness and significant visual impairment in over 2000 infants in the United States each year. Although the NEI supported CRYO- ROP Study showed that cryotherapy can reduce the incidence of adverse outcome from severe ROP, cryotherapy is a destructive, interdictive treatment which may cause permanent visual defects in otherwise successfully treated. Therefore a prophylactic therapy for ROP that would prevent visual loss related to either the disease or the treatment would be preferable to any currently available treatment modality. There is evidence to suggest that the intensity of the light in the modern neonatal nursery may be one of the contributing factors to ROP development. The proposed randomized, prospective clinical trail will examine whether reducing light to the eyes of prematurely born infants will prevent or reduce the incidence of moderate ROP. This study will also develop methods to monitor the light levels in the neonatal nurseries. If light reduction is proven to be beneficial in reducing the incidence of moderate ROP, then a practical technique of infant/light attenuation will be developed.

这是三种相互关联的财政支持申请之一